MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER; CATHETER, PERCUTANEOUS

Model Number	RFX058-125-08
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a stent encountered resistance in the navien catheter.The patient was undergoing thrombectomy.It was noted the patient's vessel tortuosity was normal.The access vessel was the femoral artery with a diameter of 8mm.It was reported that the stent did not pass through the catheter.It failed to pass after multiple attempts.It was able to pass after changing the intermediate catheter.The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Ancillary devices include a medtronic guidewire.The catheter resistance occurred in the middle section.It was noted that the pushwire or catheter was kinked.A sfr-4-20 stent was used.Additional information received reported the devices were not kinked.
Additional Manufacturer Narrative
H3: the navien catheter was returned for analysis.No damages were found with the navien catheter hub.The navien catheter body was found kinked at ~30.2cm from the catheter distal tip.The navien catheter distal tip was found to be in good condition.An in-house 0.051¿ mandrel was inserted through the navien catheter without issue.Based on the device analysis and reported information, the customer¿s ¿catheter resistance¿ report could not be confirmed as no issues were encountered during testing.The solitaire fr stent was not returned; therefore, an analysis could not be performed, and any contributing factors could not be assessed.Possible causes of ¿resistance during retrieval¿ include using an incompatible catheter, catheter damage, or patient vessel tortuosity.In this event, the use of an incompatible catheter likely contributed to the reported event.It was noted the patient's vessel tortuosity was normal; therefore, it was unlikely to contribute to the reported event.Although the navien catheter was found kinked, it was reported that there was no kink.Therefore, it is likely the navien catheter became kinked upon return to medtronic and would not have contributed to the reported event.The navien catheter has a labeled inner diameter of 0.058¿.As indicated in the solitaire fr instructions for use (ifu), the solitaire fr device should be used with a balloon guide catheter, 8-9f with a minimum inside diameter of 0.075¿.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SUPPORT GUIDECATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20932087
• Report Number: 2029214-2024-02302
• Device Sequence Number: 8314282
• Product Code: DQY
• UDI-Device Identifier: 00847536017849
• UDI-Public: 00847536017849
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/18/2024
• Device Model Number: RFX058-125-08
• Device Catalogue Number: RFX058-125-08
• Device Lot Number: B448436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female